Apparatus and method for manipulating a flexible strand and soft tissue replacement during surgery

ABSTRACT

An apparatus and method is disclosed for performing a surgery, such as an orthopedic surgery. The apparatus can include a guide portion and an alignment portion. The guide portion can assist in positioning the alignment portion to assist in aligning an implant. The implant can be aligned and positioned to hold a graft relative to a bone portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/066,519 filed on Jan. 31, 2002. The disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The present teachings relate to endoscopic soft tissue replacementfixation. More particularly, the present teachings relate to anapparatus and a method to reconstruct an anterior cruciate ligament withsoft tissue replacements within a femoral tunnel.

BACKGROUND

The knee joint is frequently the object of injury and is often repairedusing arthroscopic surgical procedures. An example of such arthroscopicsurgical procedure is the replacement of anterior cruciate ligaments ofthe knee. The tearing of these ligaments is common in sports activitiessuch as football or skiing.

Various natural and synthetic tissue replacements are used. Thereplacements can be xenograft, allograft or autograft. For example,fascia lata soft tissue replacements are flexible strands which areaffixed to a threaded stud and turned into the femoral tunnel. Hamstringsoft tissue replacements are also currently fixed over a screw in thetibial tunnel and fixed on the lateral femur. This technique requiresthe femoral tunnel to completely penetrate the femur. In addition,according to present procedures, fixation of the soft tissue replacementon the femoral side requires a large incision.

Further, various other graft portions, such as a patellar tendon graft,which can include a bone tendon bone graft can be used. The graft can beharvested from between patella and the selected bone to which the tendonis anchored. This allows for creation of a bone-tendon-bone graft wherethe tendon is already anchored to bone portions and only the boneportions are fixed relative to the implant site in the bone. Furtherexamples include a quadriceps tendon graft as various examples ofautografts. All grafts from similar sites of selected individuals canalso be used in a patient requiring a graft. Further, xenograftmaterials can be harvested from compatible animals for implantation toselected patients. Also, synthetic materials, such as those that arebiologically compatible and include appropriate physical properties canbe used. One skilled in the art is generally aware of the various typesof graft materials that can be provided for performing a graftingprocedure.

It has been difficult to insert and fasten a soft tissue replacement ina blind hole or tunnel. Attempts have been made to thread the softtissue replacement through the tunnel and over an anchor, but with somedifficulty. Thus far, the prior art has not developed a quick andefficient way to implant a soft tissue replacement over an implantedanchoring system.

While offering certain improvements in arthroscopic surgery to repairligaments, the prior art may still be improved upon to overcome thelimitations on the endoscopic hamstring soft tissue replacement fixationdue, in many instances, to the weakness of the flexible strand used tospan the gap between the tendon soft tissue replacement and the fixationpost.

Other techniques attempt to use biological fixation to augment orreplace mechanical fixation. While increasing fixation strength thesetechniques require time to fully realize their fixation potential.Additionally the techniques may take additional surgical time andresources that a purely mechanical fixation technique may not require.

SUMMARY

An apparatus including a member that acts as a flexible strand insertionand guide rod is used to increase the simplicity and effectiveness of asoft tissue implant procedure. The member inserts a flexible strand,which has been preloaded onto the insertion rod, into a blind tunnelformed in a bone structure and provides a guide for a drill point orbit. Thus the member may be removed with the flexible strand alreadypositioned in place to move an implant into the blind tunnel over thedrill point. A cross or set pin can then be moved after the drill pointinto the drill hole to lock the implant in place.

The apparatus according to various embodiments allows a method ofperforming an implant procedure. A method of surgically implanting asoft tissue replacement for attaching two bone members comprisesinserting an insertion rod having a flexible strand pre-loaded on theinsertion rod into a first tunnel. A second tunnel can be formedtransverse and through the first tunnel and the insertion rod with atool bit. A flexible strand can be reached within the first tunnel. Themethod also includes removing the insertion rod from the first tunnel.

According to various embodiments an apparatus to assist in positioning agraft in a tunnel, having a diameter, formed in a bone while performinga surgery is disclosed. The apparatus can includes a guide memberextending along a first axis and having a first end and second end. Aguide portion can extend from the first end and generally along thefirst axis. An implant alignment member positionable relative to theguide portion can also be provided. Also, an engaging member can removea portion of the alignment member from the tunnel. The alignment memberis operable to align an implant and operable to hold the graft in thetunnel.

According to various embodiments a system for positioning a soft tissuegraft in a bore formed in a bony portion of an anatomy is disclosed. Thesystem can include a guide member positionable in a portion of the bore.An implant can hold the soft tissue graft in a portion of the bore. Apositioning member can interconnect with the implant to align theimplant with the bore. Also, an assisting member can interact with thepositioning member to assist in positioning the positioning memberrelative to the soft tissue graft prior to positioning the implant.

According to various embodiments a method of surgically attaching a softtissue graft to at least one bone member is disclosed. The method caninclude inserting an insertion rod having a guide portion into a firsttunnel of the bone member. An engaging member can be positioned on theguide portion. A tunnel forming device can be positioned relative to theguide portion. A second tunnel can be formed transverse and through thefirst tunnel and relative to the guide portion. An implant aligningmember can be passed through the second tunnel and through the guidesection. An alignment suture member can be interconnected with theimplant aligning member.

Further areas of applicability of the present teachings will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the various embodiments are intended for purposes ofillustration only and are not intended to limit the scope of theteachings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present teachings will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a perspective view of the bone insertion rod affixed to aU-Guide;

FIG. 2 is a perspective view of bone insertion rod not affixed to theU-Guide;

FIG. 2A is a detail perspective view of a guide portion of an insertionrod according to various embodiments;

FIG. 3 is an exemplary view of a knee prepared for insertion of theinsertion rod;

FIG. 4 is a perspective view of the insertion rod and U-Guide insertedinto the tibia and femur tunnels with the flexible strand in place;

FIG. 5 is a view of the U-Guide and insertion rod in place with a K-WireDrill Point forming a transverse tunnel;

FIG. 6 is perspective view of the K-Wire Drill Point with the flexiblestrand affixed to a soft tissue replacement and draped over the K-WireDrill Point;

FIG. 7 is a perspective view of the soft tissue replacement pulled overthe K-Wire and out through the tibial tunnel;

FIG. 8 is a perspective view of the soft tissue replacement in place andthe ACL Cross Pin set in place in the transverse tunnel in the femur;

FIG. 9 is a deep view of the knee with an ACL replacement having itsfree ends affixed to the tibia and the femoral end affixed over the ACLCross Pin;

FIG. 10 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a measuringdevice;

FIG. 11 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a drill pointthrough the femur;

FIG. 12 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a pinalignment suture through the femur;

FIG. 13 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a pinalignment suture through the femur and a graft pusher in a firstposition relative to the femur;

FIG. 14 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a pinalignment suture through the femur and a graft pusher in a secondposition relative to the femur;

FIG. 15 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a pinalignment suture through the femur and the graft in a position relativeto the femur;

FIG. 16 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a pinalignment suture through the femur and the graft in a position relativeto the femur and aligning an implant according to various embodiments;and

FIG. 17 is an environmental perspective view of an apparatus accordingto various embodiments positioned relative to a knee with a pinalignment suture through the femur and the graft in a position relativeto the femur and fixing an implant according to various embodiments;

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

The following description of various embodiments is merely exemplary innature and is in no way intended to limit the teachings, itsapplication, or uses. Moreover, while the present teachings are directedin detail below with regard to ACL reconstruction, those skilled in theart will recognize the other types of soft tissue fixation may employthe present teachings.

Referring to FIG. 1, a generally guide apparatus 10 which may begenerally a U-shaped guide or a U-Guide generally includes an L-shapedretaining bar or L-guide 12 which includes two portions or legs, a firstportion 14 and a second portion 16, that is substantially perpendicularto the first portion 14. The first portion 14 defines a guide section18, having a guide section ledge 18 a, formed transversely through thefirst portion 14. The guide section may be a passage through ortransverse to the first portion 14 such as a bore wherein the guidesection ledge would be a bore ledge. A set screw 20 can be provided tocreate a locking mechanism for the guide section 18. The second portion16 defines a bore 22 formed transversely through the second portion 16.Also, a flexible strand notch or flexible strand retaining member 23 isformed near the bore 22 on the second portion 16. A second set screw 24is also provided to create a locking mechanism for the bore 22. TheL-guide 12 is shown in an L-shape, however, it will be understood theL-guide 12 may be any appropriate form. Generally, however, the axesdefining the guide section 18 and the bore 22 are orthogonal. Therefore,the first axis A of the guide section 18 should intersect the secondaxis B of the bore 22 at a right angle at a position.

An insertion or guide rod 26 is adjustably held in the bore 22 andlocked in place with the second set screw 24. With continuing referenceto FIG. 1 and further reference to FIG. 2, the insertion rod 26 includesa body portion 28. The body portion 28 is substantially cylindrical andformed around a longitudinal axis C. The body portion 28, which isgenerally a solid, may also taper towards the guide portion 36(described herein). Also, the body portion 28 may include depth indicia29 to give a visual indication of the depth of the insertion rod 26 intoa patient.

Extending from a first end of the body portion 28 is an L-Guide engagingportion 30 which includes a notch or projection 32 that is received inthe second portion 16 of the L-Guide 12 to ensure proper orientation ofthe insertion rod 26 to the L-Guide 12. The notch 32 on the insertionrod 26 is keyed to be received on to a portion of the second portion 16.The insertion rod 26 further includes a collar 34, having a firstshoulder 34 a and a second shoulder 34 b, to ensure that the insertionrod 26 is held at a predetermined depth in the L-Guide 12 and to furtherensure proper orientation of the insertion rod 26 relative to theL-Guide 12.

A guide portion 36 extends from a second end of the body portion 28. Theguide portion 36 includes two generally parallel legs 38 and 40 and ashoulder 41. Each leg 38, 40 extends from the body portion 28 along axisC, though offset therefrom. The two legs 38, 40 define a slot 42, wherethe slot 42 extends substantially the distance of the two legs 38, 40and has a slot ledge 42 a where the two legs 38, 40 meet at the shoulder41.

Also formed in each of the legs 38, 40 is a flexible strand groove 44.The flexible strand groove 44 may be any appropriate depth, butexemplary is substantially equal in depth to the diameter of a cord orflexible strand thread to be used with the apparatus 10. The flexiblestrand groove 44 extends, along the outside of each leg 38, 40,substantially the length of the legs 38, 40 and also over the distal endof the legs 38, 40. The flexible strand groove 44 also extends generallyalong axis C, though offset therefrom, and also over the terminal end ofeach leg 38, 40. The plane defined by the slot 42 is substantiallyorthogonal to the plane defined by the flexible strand groove may lie onany relative plane as long as the two planes intersect within the areadefined by the guide portion 36. As described herein, a tool may beplaced through the slot 42 while a cord is placed over the slot 42 bybeing positioned in the flexible strand groove 44.

The insertion rod 26 may be any desired length. Preferably, however, thedistance between the second collar shoulder 34 b and the slot ledge 42 ais equal to the distance between a first end of the first portion 14,generally represented by line D, and the guide section ledge 18 a. Inthis way, the guide section ledge 18 a and the slot ledge 42 a aregenerally equidistant from the second portion 16. Therefore, anyinstrument received through the guide section 18 would remainsubstantially parallel to the second portion 16 when it passed throughthe slot 42.

The flexible strand groove 44 can be placed orthogonally to the slot 42so that a cord, such as a flexible strand, may be placed in the flexiblestrand groove 44 to form an enclosed passage for any device that may beplaced through the slot 42. In this way, a device, such as a K-Wire(described herein), when inserted through the slot 42 a has a flexiblestrand looped over the device. It will be understood, however, that theflexible strand groove 44 may be formed at any orientation relative tothe slot 42 as long as a flexible strand placed in the flexible strandgroove 44 will overlay the slot 42.

The notch 32 ensures that the insertion rod 26 is properly oriented withthe L-Guide member 12 of the U-guide apparatus 10. In particular, theslot 42 is preferably aligned with the guide section 18. The set screw24 tightens against the L-Guide engaging portion 30 to ensure that theinsertion rod 26 does not move during a surgical procedure. Also, thisensures the proper keyed fit of the notch 32 into the second portion 16so that the guide section 18 and the slot 42 are properly aligned. Thisensures that the instrument received through the apparatus 10 isaligned. It will be understood, however, that any appropriate means maybe used to secure the insertion rod 26 to the L-Guide member 12 of theapparatus 10.

Returning briefly to FIG. 2A, the insertion or guide rod 26 can includea guide portion 36 a. The guide portion 36 a can be similar to the guideportion 36. For example, the guide portion 36 a can include a first leg38 a and a second leg 40 a and a slot 44 a similar to the slot 44. Theguide portion 36 a can also include a bore 45 a that extends as apassage 43 a through the leg 40 a. The guide portion 36 a can furtherinclude a second bore 45 b that extends as a passage 43 b through theleg 38 a. Therefore, rather than the flexible strand 62 being placed inthe slot 44, the flexible strand 62 can pass through the passages 43 a,43 b and through the bores 45 a, 45 b to be securely held relative tothe guide portion 36 a. The slot 44 a could be provided to allowmovement of the guide portion 36 a through a tunnel without impingingthe flexible strand 62. It will be understood that the guide portion 36a can be formed in any appropriate manner, such as the guide portion 36a, the guide portion 36, or any appropriate guide portion. The inclusionof the passages 43 a, 43 b, however, can assist in holding the flexiblestrand 62 at a selected position relative to the guide portion 36 a dusing insertion of the member 26.

Referring to the remaining FIGS. 3-9, an exemplary method for using theapparatus 10, including the insertion rod 26 is described. It will beunderstood that although the apparatus 10 is described in the use of anAnterior Cruciate Ligament (ACL) replacement, any appropriate surgerymay be performed with the apparatus 10 which would require itsattributes.

With particular reference to FIG. 3, a knee 50 generally includes atleast a tibia 52 and a femur 54 surrounded by soft tissue 55. The knee50 is initially prepared by forming a tibial tunnel 56 and a femoraltunnel 58 which are substantially in line with one another such that astraight and solid object could engage both the tibial tunnel 56 and thefemoral tunnel 58 without a substantial amount of stress when the kneeis placed in flexion between about 30 degrees and 110 degrees. It isunderstood that incisions must first be made in the soft tissue 55surrounding the tibia 52 such that a tool may engage the tibia 52 andthe femur 54 to form the tibial tunnel 56 and the femoral tunnel 58. Anysuitable tool may produce the respective tunnels 56, 58 such as apneumatic or electric drill or reamer. It is also understood that thefemoral tunnel 58 is a blind tunnel. A blind tunnel is a tunnel whichincludes an entrance but no discernable exit, rather a blind tunnelterminates below the surface of the femur 54.

The size of the tibial tunnel 56 and the femoral tunnel 58 depends uponthe size of the soft tissue replacement (described further herein) to beimplanted into the patient. The larger the replacement needed, thelarger the diameter of the tibial tunnel 56 and the femoral tunnel 58.The tibial tunnel 56 and femoral tunnel 58 may be of any requireddiameter, but are generally between about 5 and 18 millimeters. It wouldbe understood, however, that if a larger diameter replacement isnecessary, then larger diameter tunnels 56, 58 may be produced in thetibia 52 and femur 54 to receive the implant. Additionally, smallertunnels 56, 58 may be used if only a smaller implant is necessary. Inaddition, the largest area of the insertion rod 26 will have a diametersubstantially equal to the diameter of the tibial tunnel 56 and femoraltunnel 58. For example, if the insertion rod 26 was produced so that theguide portion 36, in particular the shoulder 41, form the largestdiameter of the insertion rod 26, then the outside diameter of the guideportion 36 would be substantially equal to diameter of the tibial tunnel56 and the femoral tunnel 58. Also, the body portion 28 may have alesser diameter, or a taper towards the shoulder 41, to ease insertionand removal of the insertion rod 26. This ensures that the insertion rod26, and particularly the slot 42, are substantially centered in thefemoral tunnel 58 for the remaining procedure.

A flexible strand 62, having a trailing end 62 a and a leading end 62 b,is placed or pre-loaded into the flexible strand groove 44 and then theinsertion rod 26 is inserted through the tibial tunnel 56 and into thefemoral tunnel 58, as best shown in FIG. 4 (see also FIGS. 1 and 2). Theflexible strand 62 may be any generally known strand suitable to thepurpose such as a mono- or poly-filament suture, a flexible wire, orcord made of any suitable material. The flexible strand groove 44 allowsthe flexible strand 62 to be inserted through the tunnels 56, 58 withoutengaging the walls of the tunnels 56, 58. Generally the depth of theflexible strand groove 44 is at least equal to the diameter of theflexible strand 62. The flexible strand 62 is placed so that it reachessubstantially to the end of the femoral tunnel 58 and the slot 42creates an opening through the center of the femoral tunnel 58 throughwhich an instrument may pass, while not interrupting the flexible strand62 which has been inserted into the femoral tunnel 58 by the insertionrod 26. The flexible strand 62 is caught in the flexible strand notch23. The flexible strand 62 is held in position during the insertion ofthe insertion rod 26 into the tunnels 56, 58 and during the remainingsurgical procedure by the flexible strand notch 23. Any suitable meansmay be used to hold the flexible strand 62 in place relative to theL-Guide member 12 of the apparatus 10. The flexible strand notch 23,which holds the flexible strand 62 with friction, is merely exemplary ofone appropriate means to hold the flexible strand 62 in place.

Once the insertion rod 26 has been inserted into the femoral tunnel 58,so that the flexible strand 62 is positioned properly, a device, such asa drill bit or point 70 is used to produce a transverse tunnel 72 in thefemur 54. The transverse tunnel 72 is formed transversely to the femoraltunnel 58. The transverse tunnel 72 will include an insertion point 72 aand an exit point 72 b. It will be understood that an incision mustfirst be made in the soft tissue 55 surrounding the femur 54, so thatthe drill bit or point 70 may engage the femur 54 to form the transversetunnel 72. The drill point 70 may be powered by any appropriate deviceknown in the art such as an electric or pneumatic drill. Furthermore,additional guide units or bullets 74, such as the U-Guide bulletproduced by Arthotek, Inc. of Warsaw, Ind., may be used to ensure theproper orientation and depth of the drill point 70. The guide bullet 74is inserted into the guide section 18 and held in place with the setscrew 20 to ensure the drill point 70 is properly aligned with the slot42 when producing the transverse tunnel 72. The transverse tunnel 72 isproduced through the entire width of the femur 54 so that the drillpoint 70 exits the femur 54 producing the exit point 72 b. This allowsthe drill point 70 to be removed through the exit point 72 b at theappropriate time. While the apparatus 10 is still in place, a cannulatedreamer (not shown) enlarges a portion of the transverse tunnel 72. Thereamed tunnel 73 receives the pin 84 (described herein). The reamedtunnel 73 does not extend the length of the transverse tunnel 72.

After the reamed tunnel 73 is produced, the apparatus 10, is removed asparticularly shown in FIG. 6. Once the apparatus 10 has been removed,the drill point 70 remains in the transverse tunnel 72. A soft tissuereplacement 80 is affixed to the trailing end 62 a of the flexiblestrand 62. The soft tissue replacement may be any suitable replacementsuch as a hamstring portion, an allograft tissue replacement, axenograft tissue replacement, or an artificial soft tissue replacementwhich may be produced from materials such as polymers or metal. Afterthe soft tissue replacement 80 has been affixed to the trailing end 62a, the leading end 62 b of the flexible strand 62 is pulled drawing thesoft tissue replacement 80 first through the tibial tunnel 56 and thenthrough the femoral tunnel 58 over the drill point 70 and back down thefemoral tunnel 58 and out through the tibial tunnel 56. This produces aloop of the soft tissue replacement 80 over the drill point 70 inside ofthe femoral tunnel 58. After being looped over the drill point 70, thetwo free ends 80 a and 80 b of the soft tissue replacement 80 extendfrom the tibial tunnel 56 adjacent to the tibia 52.

After the soft tissue replacement 80 has been looped over the drillpoint 70, an ACL cross pin or pin 84 is pulled into place in the reamedtunnel 73. The drill point 70 generally includes an eyelet 86 which willallow the attachment of the pin 84 to the drill point 70. Generally, thepin 84 is attached to the eyelet 86 through a second flexible strand 88or other appropriate means. After the pin 84 is attached to the eyelet86, the drill point 70 is pulled through the transverse tunnel 72,through the loop of the soft tissue replacement 80 and out the exitpoint 72 b. This pulls the pin 84 into position and fixes it within thetransverse tunnel 72, as particularly shown in FIG. 8. Once the pin 84has been fixed in place in the transverse tunnel 72, the attachedflexible strand 88 may be cut or otherwise disengaged from between theeyelet 86 and the pin 84. The drill point 70 is then freely removed fromthe transverse tunnel 72. This leaves the pin 84 lodged into thetransverse tunnel 72 which may be locked in place with either portionsof the pin 84 or through any other appropriate locking means. Althoughany appropriate means may be used to hold pin 84 in the reamed tunnel73, the pin 84 may include a square end to hold pin 84 in place. The pin84 may also be threaded such as the device described in U.S. Pat. No.5,674,224 entitled “Bone Mulch Screw Assembly For Industrial Fixation ofSoft Tissue Soft tissue replacements And Method For Using Same” toStephen M. Howell et al. incorporated herein by reference.

Because the pin 84 has been lodged in the transverse tunnel 72, and thesoft tissue replacement 80 is looped over the pin 84, only the free ends80 a and 80 b need to be secured to the tibia 52 to complete theimplantation. A staple 90 is used to affix the free ends 80 a and 80 bof the soft tissue replacement 80 to the tibia 52, as best shown in FIG.9. It will be understood, however, that any appropriate means may beused to affix the free ends 80 a, 80 b to the tibia 52 such as TheWasher-Loc™ tibial fixation device sold by Arthrotek, Inc., of Indiana,U.S.A.; U.S. Pat. No. 6,280,472 B1 entitled “Apparatus And Method ForTibial Fixation Of Soft Tissue” to James A. Boucher et al.; and U.S.Pat. No. 5,931,869 entitled “Apparatus And Method For Tibial Fixation OfSoft Tissue” to James A. Boucher et al. each incorporated herein byreference. Once the free ends 80 a and 80 b of the soft tissuereplacement 80 are affixed to the tibia 52, the soft tissue replacement80 securely attaches the tibia 52 and the femur 54 substantially as anatural ACL would.

It will be understood that any appropriate means may be used to affixthe soft tissue replacement 80 in the femoral tunnel 58. The pin 84 ismerely exemplary of any appropriate device to affix the soft tissuereplacement 80 in the femoral tunnel 58. Any commonly known screw orother fixation device may be used to fix the soft tissue replacement 80in the femoral tunnel 58. It will also be understood that the softtissue replacement 80 may be pulled over the pin 84 after the pin 84 hasbeen lodged in the transverse tunnel 72. In particular, if the pin 84 issmooth, the soft tissue replacement 80 may be pulled over the pin 84without damaging the soft tissue replacement 80 itself. The drill point70 is simply removed from the transverse tunnel 72 before the softtissue replacement 80 is pulled into the femoral tunnel 58.

It will also be understood that the method for performing the describedprocedure may be altered but remain within the scope of the presentlyclaimed invention. For example the flexible strand 62 may looped overthe insertion rod 26 such that the two free ends 62 a and 62 b are onone side and a loop of the flexible strand is formed on the other sideof the insertion rod 26. Thus the soft tissue replacement 80 may beaffixed to both free ends 62 a and 62 b or placed through the loop andthen pulled over the insertion rod 26.

As discussed above, the guide apparatus 10 includes a plurality ofcomponents including the L-guide portion 12, which includes a guidesection 18 defining a guide ledge 18 a. The insertion or guide rod 26can be interconnected with the L-guide 12 to form a portion of the guideapparatus 10. Although the guide apparatus 10 can be used according tovarious embodiments, including that described above, various othermethods and procedures can be performed with the similar apparatus.

It will be understood that the guide apparatus 10 can be used to performa plurality of procedures, such as assisting in replacing an anteriorcruciate ligament (ACL) in a knee joint between the femur 54 and thetibia 52. It will be understood that various procedures can beperformed, such as with initial reference to FIGS. 3-5. As described andillustrated above and briefly summarized below, a soft tissuereplacement can be performed relative to the knee 50. The tibial tunnel56 and the femoral tunnel 58 can be formed in the tibia and the femur54, respectively. It will be understood that various and appropriatelysized incisions can be made in the soft tissue 55 as necessary and anyappropriate apparatus can be used to form the tunnels 56, 58.

With reference to FIG. 10, the guide apparatus 10 can be positionedrelative to the knee 50. In particular, the guide rod 26 can bepositioned in the tunnels 56, 58. The guide rod 26 can be positioned inthe tunnels 56, 58 either prior to or after being interconnected withthe L-guide portion 12. Further, as discussed above, the guide rod 26can include an engaging member, such as a pre-loaded flexible strand 62.Once the guide apparatus 10 is positioned relative to the tibia 52 andthe femur 54 through the tunnels 56, 58, a targeting bullet or sizingmember 100 can be passed through the guide section 18. The sizing member100 can be passed through an incision made in the soft tissue 55 as willbe understood by one skilled in the art.

The sizing member 100 which can be similar to or the same as the bullet24, can include a distal or bone engaging end 102 and a proximal end 104interconnected by a body 106. The body 106 can include one or aplurality of demarcations 108 that can be referenced relative to theL-guide portion 12. The sizing member 100 can be used to select anappropriate implant, such as the graft fixation pin 84. The graftfixation pin 84 can be selected based on various characteristics, suchas the depth to the soft tissue 55, the size of the femur 54 relative tothe soft tissue 55, the depth of the femur 54, the positioning of thetunnel 58 within the femur 54, or any other appropriate consideration.Regardless, the sizing member 100 may be used during the procedure toassist in selecting an appropriate graft fixation pin 84. It will beunderstood, however, that the sizing member 100 is not necessary and anyappropriate method can be used to select the graft fixation pin 84.

After positioning the sizing member 100 relative to the guidingapparatus 10 and the femur 54, the guide wire or drill point 70 can bepositioned through the sizing member 100 and drilled through the femur54 as illustrated in FIG. 11. This can be used to form a portion of thetransverse tunnel 72 through the femur 54. As discussed above, the drillpoint 72 can pass through the guide portion or the opening 42 in theguide rod 26. The drill point 70 can be passed through the entire lengthor width of the femur 54. The drill point 70 may extend out a side ofthe femur 54 so that a distal tip 70 a of the drill point extends out ofthe femur along with a proximal end 70 b of the drill point 70. This mayallow for either end of the drill point 70 to be operated for variouspurposes, such as those described herein. It will be understood,however, that the drill point 70 can be passed through the femur 54 inany appropriate manner with the use of the guide apparatus 10, withoutthe use of the guide apparatus 10, or with or without the sizing member100. The drill point 70 can be powered by hand or with a power tool, orin any appropriate manner. It will be understood that the guidingapparatus, if used, can include portions that allow the drill guide 70to be positioned relative to the femur 54 in any appropriate manner.

Once the drill point 70 is passed through the femur 54, such as bydrilling the drill point 70 through the femur, a portion of thetransverse tunnel 72 can be enlarged. A drill bit 110 can be used toform the enlarged portion 73 of the transverse tunnel 72. The drill bit110 can also be powered in any appropriate manner such as with a powerdrill motor, a hand tool, or the like. Further, the drill bit 110 can beany appropriate member that is able to perform the enlargement oftransverse tunnel 73. For example, a reamer, a cannulated drill bit, orany other appropriate tool can be used to form the enlarged transversetunnel 73.

The drill bit 110 can be drilled over the drill point 70 to anyappropriate depth in the femur 54. For example, the drill bit 110 can bedrilled into the femur 54 until it reaches or bottoms out on the guiderod 26. Therefore, when the drill bit 110 reaches the guide rod 26, itwill be understood that the drill bit 110 has formed the enlarged tunnel73 from an exterior of the femur 54 to at least a portion of the femoraltunnel 56. The enlarged and tunnel portion 73 can be used for anyappropriate portion, such as positioning the cross pin or bullet 84 intothe femur 54.

Once the enlarged portion 73 of the transverse tunnel is formed, atransverse pin alignment suture or flexible member 112 can beinterconnected with an eyelet 70 c formed on the drill point 70, asillustrated in FIG. 12. The transverse pin alignment suture 112 can thenbe drawn through the transverse tunnel 72 by withdrawing the drill point70 therefrom. An external portion of the suture 112 can be clamped orheld in place with any appropriate mechanism such as with a clamp 114.

Once the pin alignment suture 112 is drawn through the transverse tunnel72, the guide apparatus 10 can be substantially removed from the knee50. The flexible member 60 that is initially loaded on the guide rod 26can be used to withdraw a portion of the pin alignment suture 112 out ofthe tibial tunnel 56. The portion of the suture 112 drawn out of thetibula tunnel 56 can be clipped to any appropriate portion or held in arelative location such as being clipped with a clip 116 to a drape 118,as illustrated in FIG. 13. It will be understood, however, that the pinalignment suture 112 can be held in any appropriate manner exterior tothe tibia 52. Although it has been disclosed above that the flexiblemember can be used to withdraw a portion of the pin alignment suture 112from the tibial tunnel 56, it will be understood that any appropriateenlargement mechanism can be provided. For example, a releasable member,such as a finger or a clip, can be formed on the guide rod 26 that canbe used to withdraw the pin alignment suture 112. Therefore, it will beunderstood, that the flexible member 60 is merely exemplary of amechanism or instrument to withdraw a portion of the pin alignmentsuture 112.

Once the pin alignment suture 112 has been held in a selected position,such as with the clip 116, a soft tissue graft 120 can be interconnectedwith a positioning tool 124, as illustrated in FIG. 14. The soft tissuegraft 120 can include any appropriate soft tissue, such as an allograft,a xenograft, an autograft, or combinations thereof. The soft tissuegraft 120 can be formed or prepared in any appropriate manner. Forexample, ends of the soft tissue graft can be intertwined or suturedtogether with a graft suture 126. The intertwined end 128 of the softtissue graft 120 are thereby held relative to one another forimplantation of the soft tissue graft 120.

The positioning instrument 124 can include any appropriate mechanism toassist in positioning the soft tissue graft 120 in the tunnels 56, 58.For example, the positioning instrument 124 can include a positioningarm 128 and a T bar or handle 130. The positioning arm 128 can include adistal fork or graft engaging portion 132. The handle 130 can includeany appropriate configuration to allow for interconnecting the sutures126 therewith. Interconnecting the sutures 126 with the handle 130 canassist in holding the soft tissue 120 relative to the positioninginstrument 124 for a selected period of time. It will be understood,however, that the fork 132 can be any appropriate portion and a fork ismerely exemplary.

The soft tissue graft 120 can be sized in any appropriate manner. Forexample, the soft tissue graft 120 can include a dimension, a volume, adiameter, or the like that can substantially fill at least a portion ofthe femoral tunnel 58 or the tibial tunnel 56. It will be understood,however, that the soft tissue graft 120 can be formed in any appropriatesize for achieving a selected result. The positioning instrument 124allows the graft 120 to be positioned into the tunnel, such as allowingit to be substantially seated in the tibial tunnel 58 without theassistance of any other mechanisms. The graft positioning member 124allows the graft 120 to be passed through the tunnels 56, 58 with easeby a user, such as a physician. The positioning member 124 also enablesa size specific graft that is sized to fill the diameter of the tunnels56, 58 to be moved into the tunnels. The tunnels 56, 58 can be formed tosubstantially match a dimension of the graft for various purposes suchas initial fixation and bone ingrowth.

As discussed above, the positioning instrument 124 allows for pushingthe soft tissue graft 120 into the tunnels 56, 58. Because the softtissue graft 120 is pushed into the tunnels 56, 58, the soft tissuegraft can be formed to substantially fill the tunnels so that asubstantial force can be used push the soft tissue graft 120 into thetunnels 56, 58. It will be understood that the force used may not cut orotherwise deteriorate the graft 120, but the force may be substantialdue to the positioning instrument 154.

Further, the tunnel is formed in the anatomy, such as the femoral tunnel58 can be sized such that the tibia tunnel extends a selected distancepast the transverse tunnel 72. The transverse tunnel 72 can be formedrelative to the femoral tunnel 58 such that there is a head room ordistance that is formed by the femoral tunnel 58 that is past or extendspast the transverse tunnel 72. As discussed above, the guide bit 70generally assists in positioning the implant 130 relative to the softtissue graft 120 after the soft tissue graft 120 is in position in thefemoral tunnel 56. Therefore, the soft tissue graft 120 can be pushedinto the femoral tunnel 56 such a distance that the implant 120 does notsubstantially interact with or contact the soft tissue graft 120 as itis passed through the transverse tunnel 72 as discussed further herein.This can be provided for various reasons such as easing the positioningof the implant 130 relative to the soft tissue graft 120 and the femoraltunnel 56. Because the soft tissue graft 120 is substantially pushedpast the transverse tunnel 72, the implant 130 can be easily andefficiently moved past and/or through the femoral tunnel 56 withoutsubstantially contacting the soft tissue graft 120 while moving theimplant 130.

With reference to FIG. 14, once the graft 120 has been positioned in aselected location in the tibial tunnel 58, the clip 116 holding the pinalignment suture 112 at a selected location exterior to the femur 54 canbe released. The pin placement suture 112 forms a loop 112 a that isclipped with a clip 116. The loop 112 a can be positioned relative tothe soft tissue graft 120 such that the positioning suture 112 can beplaced between the portions of the soft tissue graft 120.

With reference to FIG. 15, the soft tissue graft 120 can include a firstor anterior portion 120 a and the second or posterior portion 120 b. Thesuture positioning loop 112 a can be positioned between and/or below thetwo portions 120 a, 120 b of the soft tissue graft 120. Once the loop112 a is positioned relative to, such as below, the portions of the softtissue graft 120, the positioning suture 112 can be held within thefemoral tunnel 58 such as with the clamping member 114. Regardless, thepin alignment suture 112 can be formed or made taut within the femoraltunnel by moving it generally in the direction of the arrow M. It willbe understood that the graft positioning instrument 124 can bedisconnected from the soft tissue graft 120 to allow for the loop 112 ato be passed between the portions 120 a, 120 b of the soft tissue graft120.

The pin alignment suture 112 can be used to move the drill point 70through at least a portion of the transverse femoral tunnel 72. Thedrill point 70 can also act as an implant alignment or positioningmechanism. Therefore, the drill point 70 is generally pulled under thegraft 120 such as between the two portions 120 a, 120 b. The pinpositioning suture 112 assists in pulling the drill point beneath thegraft 120.

With reference to FIG. 16, an implant 130 can be passed over the guidewire drill point 70. The implant 130 may be similar to the implant 84for holding the soft tissue graft 120 relative to the femur 54. Theimplant 30, however, can include other portions. For example, theimplant 130 may be cannulated such that it is able to pass over thedrill point 70. Further, it may include a proximal threaded or boneengagement portion 132 and a distal tunnel engagement portion 134. Theimplant 130 can include a tapered structure such that it is able to passunder the graft 120 in a non-binding manner.

The implant 130 may pass over the drill wire 70 in any appropriatemanner such as with a tool, annularly or the like. Once the implant 130is positioned relative to the femur 54, it can be fixed relative to thefemur 54 in any appropriate manner. For example, a driving tool 140 mayengage a portion of the implant 130 such as a tool engaging portion ofthe implant 130, as illustrated in FIG. 17. The tool engaging portion ofthe implant 130 can include an interior tool engaging portion such thatthe bone engaging portion 132 can extend substantially to an end of theimplant 130. The bone engaging portion 132 can include threads such thatoperation of the tool 140 acts to rotate the implant 130 so the threadsare able to engage the femur 54.

The implant 130 can include a main body portion that engages theenlarged transverse tunnel 73 while the distal portion 134 engages theunenlarged transverse tunnel 72. It will be understood, however, thatthe implant 130 can be formed in any appropriate manner to engage thefemur in any appropriate manner to allow fixation of the graft 120thereto.

The tool 140 can include a measurement sleeve 142 that is able to assistin determining an appropriate driven distance of the implant 130. Themeasuring sleeve 142 can include demarcations that allow it to be usedto determine whether the implant 130 has been driven an appropriatedistance into the femur 54. The demarcations on the sleeve 142 can bereferenced to the demarcations on the sizing member 100 to ensure thatthe implant 130 is positioned relative to the femoral tunnel 58 in anyappropriate manner to hold the graft 120.

Once the implant 130 has been positioned relative to the femur 54through the transverse tunnel 72, 73, the soft tissue graft 120 can befixed to the tibia 52 in any appropriate manner such as that describedabove. For example, the implant 90 can be used to fix the proximal endof the soft tissue relative to the tibia 52, as illustrated in FIG. 9.

It will be understood that any appropriate implants may be used for thevarious implants described herein. For example, the AXL™ cross pinproduced by Arthrotek, Inc. of Warsaw, Ind. can be used by the implant130. Further, the tibial fixation implant can be any appropriate implantsuch as the Bone Mulch™ Screw or LactoSorb™ Cross Pin produced byArthrotek, Inc. of Indiana, U.S.A. or the Trans Fix™ implant by Arthrex,Inc.

It will be understood that the method described herein can be used toposition a soft tissue graft relative to any appropriate portion of theanatomy. Although replacement of a soft tissue portion in a femur 54 anda tibia 52 have been described, interconnection of any appropriate boneportions can be formed with the various instruments and methods taughtherein.

The teachings herein are merely exemplary in nature and, thus,variations that do not depart from the gist thereof are intended to bewithin the scope of the teachings. Such variations are not to beregarded as a departure from the spirit and scope of the teachings.

1. A method of positioning a soft tissue graft into a bore formed in abone, comprising: forming a loop of soft tissue; forming a first bore ina first bone; forming a second bore in a second bone, and a third borein the second bone at an angle to the second bore; passing a suture intothe third bore such that a portion of the suture is disposed outside atleast an end of the third bore; withdrawing another portion of thesuture through the second bore and the first bore; pushing the loop ofsoft tissue graft into the first bore formed in the first bone and intothe second bore formed in the second bone; pulling at least one portionof the suture outside of the third bore to draw the withdrawn portionthrough the first bore and into the second bore to position the suturebelow the loop of soft tissue in the second bore after pushing the softtissue graft into the second bore; coupling the suture to an implantguiding member and further pulling the suture to draw the implantguiding member into the third bore and under the loop of soft tissue;and fixing the soft tissue graft to the bone by guiding an implant withthe implant guiding member.
 2. The method of claim 1, furthercomprising: fixing the soft tissue graft to the first bone.
 3. A methodof positioning a soft tissue graft into a bore formed in a bone,comprising: forming a first bore in a first bone; forming a second borein a second bone and a third bore in the second bone at an anglerelative to the second bore such that the third bore intersects thesecond bore; positioning a flexible member through the third bore suchthat portions of the flexible member are disposed outside of each end ofthe third bore; withdrawing another portion of the flexible memberthrough the second bore and the first bore; engaging the soft tissuegraft portion and holding the soft tissue graft in a selectedorientation with a graft engaging portion; allowing the soft tissuegraft to lie between two portions of a fork of the graft engagingportion; grasping a handle by a user intraoperatively; manipulating theengaged soft tissue graft portion via a member interconnecting saidgraft engaging portion and said graspable handle so that movement ofsaid graspable handle translates into movement of said graft engagingportion; pushing of said handle to move the soft tissue graft into thefirst bore and then into the second bore; pulling at least one portionof the flexible member outside of the third bore to draw the withdrawnportion through the first bore and into the second bore to position theflexible member below the soft tissue graft in the second bore afterpushing the soft tissue graft into the second bore; coupling saidflexible member to an implant guiding member and further pulling theflexible member to draw the implant guiding member into the third boreand under the soft tissue graft; fixing the soft tissue graft to thebone by guiding an implant with the implant guiding member; and engaginga suture in the handle, wherein a suture fixed to a portion of the softtissue graft is engaged on the handle.
 4. The method of claim 3, furthercomprising: pushing a specifically sized soft tissue graft into the borewith at least one of the graft engaging portion, the member, orcombinations thereof.
 5. A method of positioning a soft tissue graftinto a bore formed in a bone, comprising: forming a first bore in afirst bone; forming a second bore in a second bone; forming a third borein the second bone at an angle relative to said second bore; positioninga suture through the third bore such that a portion of the suture isdisposed and temporarily retained outside of each end of the third bore;withdrawing another portion of the suture through the second bore andthen the first bore, and temporarily retaining the withdrawn portionoutside of the first bore; positioning the soft tissue graft over aportion of a pushing instrument; fixing an end of the soft tissue graftto a graspable portion of the pushing instrument; pushing the softtissue graft through the first bore formed in the first bone with thepushing instrument; and pushing the soft tissue graft into the secondbore after pushing the soft tissue graft through the first bore; pullingat least one portion of the suture outside of the third bore to draw thewithdrawn portion through the first bore and into the second bore toposition the suture below the soft tissue graft in the second bore afterpushing the soft tissue graft into the second bore; passing an implantthrough said third bore to fix the soft tissue graft to the second boneafter the soft tissue graft has been pushed into an end of the secondbore; and guiding said implant with an implant guiding member, whereinsaid guiding includes further pulling the suture to draw the implantguiding member into the third bore and under the soft tissue graft. 6.The method of claim 5, further comprising: fixing the soft tissue graftto the first bone.
 7. A method of positioning a soft tissue graft into abore formed in a bone, comprising: forming a tibial tunnel in a tibia;forming a first femoral tunnel in a femur; forming a second femoraltunnel in the femur at an angle relative to said first tunnel;positioning a suture through the second femoral tunnel, the suture beingcoupled to an implant guiding member outside of one end of the secondfemoral tunnel and retained outside the second femoral tunnel at anopposite end of the second femoral tunnel; withdrawing a portion of thesuture through the first femoral tunnel and the tibial tunnel, andtemporarily retaining the withdrawn portion outside the tibial tunnel;forming a loop of soft tissue; positioning the loop of soft tissue on asoft tissue pusher instrument; pushing the loop of soft tissue graftinto the tibial tunnel with the soft tissue pusher instrument; pushingthe soft tissue graft into the first femoral tunnel; pulling at leastone portion of the suture disposed outside of the second femoral tunnelto draw the withdrawn portion through the tibial tunnel and into thefirst femoral tunnel to position the suture below the loop of softtissue pushed into the first femoral tunnel; passing an implant throughsaid second femoral tunnel and under the loop of soft tissue to fix thesoft tissue graft to the femur after the soft tissue graft has beenpushed into an end of the first femoral tunnel, wherein the soft tissueimplant engages the implant and is held relative to the second femoraltunnel within the femur; and guiding said implant with an implantguiding member, wherein said guiding includes further pulling the sutureto draw the implant guide member into the second femoral tunnel andunder the loop of soft tissue.
 8. The method of claim 7, furthercomprising: fixing the soft tissue graft to the tibia.
 9. The method ofclaim 7, wherein the soft tissue pusher instrument and the soft tissuegraft are sized to fit within the tibial tunnel and the first femoraltunnel without binding.
 10. The method of claim 1, wherein forming athird bore includes forming a third bore through the second bone and atan angle to the first bore.
 11. The method of claim 1, wherein forming asecond bore includes forming a second closed end bore in a second bone.12. The method of claim 3, wherein the flexible member includes asuture.
 13. The method of claim 3, wherein withdrawing another portionof the flexible member further includes temporarily retaining thewithdrawn portion outside of the first bore.
 14. The method of claim 13,further comprising retaining the withdrawn portion with a retentionmechanism.
 15. The method of claim 5, wherein pulling at least oneportion of the suture outside of the third bore includes pulling bothportions of the suture disposed outside of the third bore.
 16. Themethod of claim 7, wherein the withdrawn suture portion forms a loop,and wherein the formed loop of soft tissue includes respective endportions, the loop portion of the suture being positioned between thesoft tissue end portions and below the soft tissue loop portion.
 17. Themethod of claim 7, further comprising maintaining the loop portion ofthe suture outside the tibial tunnel while pushing the loop of softtissue graft into the tibial tunnel and first femoral tunnel.
 18. Themethod of claim 7, wherein the loop of soft tissue is pushed to aterminal end of the first femoral tunnel that is beyond the secondfemoral tunnel such that the implant can be guided through the secondand first femoral tunnels without substantially contacting the softtissue implant.
 19. The method of claim 7, wherein pulling at least oneend of the suture includes pulling the retained end while maintainingthe guiding member outside the second femoral tunnel.
 20. A method ofpositioning a soft tissue graft into a bore formed in a bone,comprising: forming a first bore in the bone; forming a second bore inthe bone at an angle to and intersecting the first bore; passing asuture into the second bore and out of the first bore such that thesuture forms a loop outside of the first bore; positioning a loop ofsoft tissue over the suture loop; pushing the looped soft tissue intothe first bore; positioning the suture below the looped tissue in thefirst bore; coupling a portion of the suture to an implant guide memberoutside of one end of the second bore and retaining another portion ofthe suture outside of an opposite end of the second bore; pulling thesuture to draw the implant guide member into the second bore and underthe loop of soft tissue; and fixing the soft tissue to the bone byguiding an implant with the implant guide member.
 21. The method ofclaim 20, further comprising maintaining the suture loop outside of thefirst bore while pushing the looped soft tissue into the first bore. 22.The method of claim 20, wherein forming the second bore includes formingthe second bore through the bone at an angle to and intersecting thefirst bore.
 23. The method of claim 20, wherein positioning the suturebelow the looped tissue in the first bore includes pulling both portionsof the suture disposed outside of the second bore to draw the sutureloop into the first bore and position the suture below the looped tissuein the first bore.
 24. The method of claim 20, wherein pushing thelooped soft tissue into the first bore includes pushing the looped softtissue into the first bore to a terminal end of the first bore, theterminal end of the first bore extending beyond the intersection of thesecond bore with the first bore.